DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: "breath delivery portion" in claims 1,14, and 20 and “breath storage portion” in claims 1 and 9-10.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f), they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. The specification defines a “breath delivery portion as being comprised of: “a breath receiving tube (2.1) connected to the breath delivery tube (1.2.2) of the breath flow adjustment tube (1.2), a pump (2.2) connected to the breath receiving tube (2.1) for controlling the breath flow rate, and a breath output tube (2.3) connected to the pump (2.2) for transferring the breath to the breath storage portion (3) at a region near the sensor (4)” (Spec Page 5 Lines 21-25). The specification defines a “breath storage portion as being comprised of: ”a storage chamber (3.1), an inlet (3.2) arranged above the storage chamber (3.1) to serve as a channel for inputting the breath received from the breath delivery portion (2) and a moisture discharge port (3.3) arranged underneath the storage chamber (3.1)” (Spec Page 6 Lines 6-9).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 21-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 21 contains a processor with “a feature generating portion for generating, via an artificial intelligence method features”. There is no support within the description for using an artificial intelligence method for generating features. Paragraph [0045] of the specification states that signals from the sensor are “analyzed to identify the features”, but fails to specify how the features are identified.
Claim 22 contains “feature generating portion generates features from the voltage data signal of the sensor “There is no description within the specification for how the feature generation portion generates features from the voltage data. Paragraph [0045] of the specification states that “the feature generating portion generates features from the voltage data signal of the sensor”, but fails to specify how the features are generated.
Claims 1-13, 15-16, 18-22, and 24-28 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Claim 1 contains the phrase “wherein the breath storage portion (3) comprises a storage chamber” in line 22, it is unclear if this is the same storage chamber in line 8 of the same claim. For purposes of examination, it is assumed it is the same storage chamber mentioned in line 8.
Claims not explicitly rejected above are rejected because they depend from claims rejected above as indefinite.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-7, 15, and 24-27 are rejected under 35 U.S.C. 103 as being unpatentable over Shaw (US 20070093725 A1- previously cited) in view of in view of Candell (US 20180125391 A1 - previously cited) in view of Causevic (WO 2014127044 A1).
In regards to claim 1, Shaw teaches a portable breath gas analyzer comprising:
a breath input portion for inputting the breath into the analyzer by blowing breath (Shaw Fig 2. collection tube 202 [0030]),
a breath delivery portion (Shaw Fig 3, First portion 302, [0036]) connected to the breath input portion,
a breath storage portion (Shaw Fig 3, Second portion 304, [0036]) connected to the breath delivery portion,
a sensor (Shaw Fig 5A, Sensor 560, [0036]) provided in the breath storage portion for detecting the breath,
and a microcontroller (FIG 5A, control unit 508) connected to the sensor for receiving the breath data from the sensor to analyze the gas and volatile substance data ([0036-0038] and [0043-0044]),
characterized in that the breath input portion comprises a mouthpiece (Light ring 502 acts as a mouthpiece FIG. 5a) having a breath input channel (Fig 5A, 204) for the users to blow breath,
a breath flow adjustment tube (FIG 3 Collection tube 202 which has two ends) connected to the mouthpiece,
and an end portion (second Light ring 502 opposite to mouthpiece FIG. 5a)) connected to the breath flow adjustment tube, having a breath output channel (Fig 5A, 204) wherein the breath flow adjustment tube comprises a main tube arranged between the mouthpiece and the end portion of the breath input portion (the collection tube 202 extends between the two end portions 502),
and a breath delivery tube (Fig 2, 206) arranged underneath the main tube to serve as a channel allowing the breath to continue to flow to the breath delivery portion.
Shaw does not explicitly teach the breath delivery tube being installed at a position 0.5 to 75 mm far from the mouthpiece in a horizontal direction. It is noted that Applicant has not disclosed in the specification that the claimed horizontal distance between the breath delivery tube and the mouthpiece provides an advantage or unexpected result. As such, it would have been obvious, through routine experimentation, to determine an optimum distance between the breath delivery tube and mouthpiece of Shaw. Furthermore, “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Alternatively or additionally, it has been held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (See MPEP 2144.04 citing Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)).
Shaw fails to teach the analyzer wherein the breath storage portion comprises a storage chamber, an inlet arranged above the storage chamber to serve as a channel for inputting the breath received from the breath delivery portion and a moisture discharge port arranged underneath the storage chamber, wherein the sensor is positioned underneath a storage chamber, and the storage chamber has a height ranging from 30 to 70mm. However, Candell teaches a device for analyzing breath wherein a breath storage portion comprises a storage chamber, an inlet arranged above the storage chamber to serve as a channel for inputting the breath received from a breath delivery portion and a moisture discharge port arranged underneath the storage chamber (see annotated Fig 27 below).
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Candell Annotated Fig 27
Shaw and Candell are both considered to be analogous to the claimed invention because they are in the same field of evaluation by breath analysis. It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the storage portion of Shaw to include the storage chamber, inlet, and moisture discharge port of Candell. Doing so would allow for the exit of breath from the storage chamber which allows for sustained breath sampling (Candell [0227]).
Shaw in view of Candell fails to teach a device wherein the sensor is positioned underneath a storage chamber, and the storage chamber has a height ranging from 30 to 70mm. Causevic teaches a sensor positioned underneath a storage chamber as well as a flow generator used to either channel the gas being purged, or drawing the captured samples through the gas analyzers ([0116] Fig 20-22 (sample tube 18 is a storage chamber, composition sensor 14 is a sensor). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the device of Shaw in view of Candell to have the sensor located under the storage portion and include the flow generator of Causevic. Doing so would allow the device to only send breath samples taken at the end-tidal section of a breath sample to the sensor for analysis as a correlation exists between the end-tidal gas level and the level of the metabolite or chemical in the body ([0003]).
Shaw in view of Candell in view of Causevic does not explicitly teach the storage chamber having a height ranging from 30 to 70 mm. It is noted that Applicant has not disclosed in the specification that the claimed storage chamber height provides an advantage or unexpected result. As such, it would have been obvious, through routine experimentation, to determine an optimum height of the storage chamber of Shaw in view of Candell in view of Causevic. Furthermore, "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Alternatively or additionally, it has been held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (See MPEP 2144.04 citing Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)).
In regards to claim 2, modified Shaw also teaches a tube having a breath flow channel on the inner side, the end portion of the breath flow channel on the side which is connected to the breath output channel being tapered toward the breath output channel ([0034] “In some embodiments, the diameter of the hollowed core of collection tube 202 decreases toward the center of the tube as depicted in FIG. 3”.).
In regards to claim 3, modified Shaw does not explicitly teach the main tube having a length of 15-80 mm. It is noted that Applicant has not disclosed in the specification that the claimed length of the main tube provides an advantage or unexpected result. As such, it would have been obvious, through routine experimentation, to determine an optimum length of the main tube of modified Shaw. Furthermore, “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Alternatively or additionally, it has been held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (See MPEP 2144.04 citing Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)).
In regards to claim 4, modified Shaw also teaches the breath delivery tube is arranged such that it is perpendicular to the horizontal axis of the main tube (Fig 2-5 shows 206 perpendicular to 202).
In regards to claim 5, modified Shaw also teaches the breath delivery tube being round and hollow (206 is shown to be round in fig 4b). modified Shaw does not explicitly teach the breath delivery tube having a diameter ranging from 0.5 to 5mm. It is noted that Applicant has not disclosed in the specification that the claimed diameter of the breath delivery tube provides an advantage or unexpected result. As such, it would have been obvious, through routine experimentation, to determine an optimum diameter of the breath delivery tube of modified Shaw. Furthermore, “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Alternatively or additionally, it has been held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (See MPEP 2144.04 citing Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)).
In regards to claim 6, modified Shaw teaches a main tube and a breath delivery tube made out of polyethylene ([0033] “In some embodiments, collection tube 202 and airway tube 206 are made out of a plastic or a rubber. In some embodiments, collection tube 202 and/or airway tube 206 are made out of high-density polyethylene”).
In regards to claim 7, modified Shaw teaches an aperture for a breath input channel and a breath output channel (Fig 5A, both instances of 204). modified Shaw does not explicitly teach the input aperture having a diameter ranging from 0.5 to 15 mm or the output aperture having a diameter ranging from 0.5 to 5 mm. It is noted that Applicant has not disclosed in the specification that the claimed diameters of the input and output tubes provides an advantage or unexpected result. As such, it would have been obvious, through routine experimentation, to determine optimum diameters of the input and output tubes of modified Shaw. Furthermore, “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Alternatively or additionally, it has been held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (See MPEP 2144.04 citing Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)).
In regards to claim 15, modified Shaw does not explicitly teach the storage chamber having a volume ranging from 0.10 to 3 liters. It is noted that Applicant has not disclosed in the specification that the claimed storage chamber volume provides an advantage or unexpected result. As such, it would have been obvious, through routine experimentation, to determine an optimum volume of the storage chamber of modified Shaw. Furthermore, “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Alternatively or additionally, it has been held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (See MPEP 2144.04 citing Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)).
In regards to claim 24, modified Shaw teaches the analyzer of claim 1 further comprising a display for displaying the results of gases and volatile substances analysis (FIG 5A, display device 504).
In regards to claim 25, modified Shaw teaches the analyzer of claim 24 further comprising a display with a monitor ([0042] “In some embodiments, display 504 is an LCD display. In some embodiments, display 504 is any kind of display that can display alphanumeric characters”).
In regards to claim 26, modified Shaw teaches the analyzer of claim 1 further comprising a housing (7) for covering the portable breath gas and volatile substance analyzer such that the mouthpiece (1.1) of the breath input portion (1) extends outwardly ([0048] “FIG. 5B illustrates a breathalyzer 500 complete with a casing.” The mouthpiece extends outwardly from the case).
In regards to claim 27, modified Shaw does not explicitly teach the main tube having a length of 30-50 mm. It is noted that Applicant has not disclosed in the specification that the claimed length of the main tube provides an advantage or unexpected result. As such, it would have been obvious, through routine experimentation, to determine an optimum length of the main tube of modified Shaw. Furthermore, “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).Alternatively or additionally, it has been held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (See MPEP 2144.04 citing Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Shaw (US 20070093725 A1- previously cited) in view of in view of Candell (US 20180125391 A1 - previously cited) in view of Causevic (WO 2014127044 A1) as applied to claim 1, further in view of Bajtala (US 20210076980 A1).
In regards to claim 8, modified Shaw teaches the portable breath gas analyzer according to claim 1. Modified Shaw fails to teach the mouthpiece, the breath flow adjustment tube, and the end portion connected together in a detachable manner. However, Bajtala teaches making individual elements of a breath input portion detachable so they can be cleaned. ([0069] “In the embodiment as depicted in FIG. 1A-C, the mouthpiece (2.1) is detachable from the breath flow adjustment tube (2)”).
Bajtala is considered to be analogous to the claimed invention because they are in the same field of breath analysis. It would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the elements of modified Shaw to be detachable like the elements of Bajtala to allow them to be cleaned (Bajtala [0096]).
Claims 9-10, 13, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Shaw (US 20070093725 A1- previously cited) in view of in view of Candell (US 20180125391 A1 - previously cited) in view of Causevic (WO 2014127044 A1), as applied to claim 1, in view of Atsalakis (US 20190120821 A1- previously cited).
In regards to claim 9, modified Shaw teaches the portable breath gas analyzer according to claim 1. Modified Shaw fails to teach the breath delivery portion comprising a breath receiving tube connected to the breath delivery tube the breath flow adjustment tube, a pump connected to the breath receiving tube for controlling the breath flow rate, and the breath output tube connected to the pump for transferring the breath to the breath storage portion at a region near the sensor. However, Atsalakis teaches a breath analysis device wherein a breath delivery portion (Atsalakis Fig.1, upstream portion 14a) comprises a breath receiving tube (See annotated FIG 1 bellow) connected to a breath delivery tube (Atsalakis Fig.1, Nafion® tube 4) of a breath flow adjustment tube (See annotated FIG 1 bellow), a pump (Atsalakis Fig.1, Pump 5) connected to the breath receiving tube for controlling the breath flow rate, and a breath output tube (See annotated FIG 1 bellow) connected to the pump for transferring a breath to a breath storage portion at a region near a sensor (Atsalakis Fig.1, 14b). Atsalakis teaches that the pump ensures a constant flow rate across the sensors to ensure accurate readings of the sensors (Atsalakis [0020]).
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Atsalakis Annotated Fig. 1
Atsalakis is considered to be analogous to the claimed invention because they are in the same field of evaluation by breath analysis. It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify modified Shaw to include the breath flow pump configuration of Atsalakis. Doing so would “ensure accurate readings of the sensors” (Atsalakis [0020]).
In regards to claim 10, modified Shaw in view of Atsalakis teaches the portable breath gas analyzer according to claim 9. As shown in Figure 1 of Atsalakis, in the combination of Shaw in view of Atsalakis, the pump would be installed separately close to the breath storage portion (Atsalakis Fig.1, pump 5 is separate from the storage portion 14b).
In regards to claim 13, modified Shaw teaches the portable breath gas analyzer according to claim 9, wherein the breath receiving tube and the breath output tube are made of a material which is silicone or Teflon (Shaw [0031]).
In regards to claim 20, modified Shaw teaches the device of claim 1 and a microcontroller that comprises a processor (“control unit 508 is implemented as one or more digital signal processors” Shaw [0043]). modified Shaw fails to teach a controller for controlling the operation of the breath delivery portion. As noted above in regards to claim 9, it would be obvious to a person of ordinary skill in the art to modify Shaw to include the breath flow pump configuration of Atsalakis. Atsalakis also teaches using a microcontroller to control the operation of the pump (“The microcontroller may also power the pump” Atsalakis [0022]).It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify controller of modified Shaw to control the operation of the pump as taught by Atsalakis. Doing so would merely be the combination of prior art elements according to known methods to obtain predictable result of electronically controlling the breath flow pump (MPEP 2143.I)
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Shaw (US 20070093725 A1- previously cited) in view of in view of Candell (US 20180125391 A1 - previously cited) in view of Causevic (WO 2014127044 A1), in view of Atsalakis (US 20190120821 A1- previously cited) as applied to claim 9, further in view of Cristoni (US 20160299125 A1- previously cited).
In regards to claim 11, modified Shaw teaches the device of claim 9. They fail to teach the pump controlling the breath flow rate to be within a range of 0 to 3 L/min. However, Cristoni teaches a pump to control breath rate within a range of 1 and 5 L/min (Cristoni [0067] “Moreover the pump 17 can operate at different flow rate ranging from 0,1 to 10 L/min, with the best preferred flow ratio being selected between 1 and 5 L/min”). Cristoni is considered to be analogous to the claimed invention because they are in the same field of evaluation by breath analysis. It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the pump of modified Shaw to operate at a flow rate of 0-3 L/min. Doing so would “permit an accurate and reproducible collection of the breath” (Cristioni [0066]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Shaw (US 20070093725 A1- previously cited) in view of in view of Candell (US 20180125391 A1 - previously cited) in view of Causevic (WO 2014127044 A1), in view of Atsalakis (US 20190120821 A1- previously cited) as applied to claim 9, further in view of Allsworth (US 20170303822 A1).
In regards to claim 12, modified Shaw teaches the portable breath gas analyzer according to claim 9. Modified Shaw fails to teach the pump being operated intermittently with an operation period being 0.06 to 1 minute. Allsworth teaches a breath collection device that uses a pump, the collection device having a collection period of 30 seconds. It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the pump of modified Shaw to operate on a collection period of 30 seconds like the device of Allsworth. Doing so would merely be a simple substitution of one mode of pump operation (intermittent) for another (continuous) to obtain predictable results.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Shaw (US 20070093725 A1- previously cited) in view of in view of Candell (US 20180125391 A1 - previously cited) in view of Causevic (WO 2014127044 A1) as applied to claim 1, in view of Lewis (US 20010041366 A1).
In regards to claim 16, modified Shaw does not explicitly teach the storage chamber having a cylindrical shape. Lewis teaches a cylindrical storage chamber ([0035]). It would have been obvious to use such a cylindrical shape since it permits for easier assembly and use. It is noted that Applicant has not disclosed in the specification that the claimed storage chamber shape provides an advantage or unexpected result. As such, it would have been obvious, through routine experimentation, to determine an optimum shape of the storage chamber of modified Shaw. Furthermore, the configuration of the claimed storage chamber is a "matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence" that the particular configuration of the claimed storage chamber was significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966)
Furthermore, modified Shaw does not explicitly teach the storage chamber having a diameter ranging from 15 to 35 mm. It is noted that Applicant has not disclosed in the specification that the claimed storage chamber diameter provides an advantage or unexpected result. As such, it would have been obvious, through routine experimentation, to determine an optimum diameter of the storage chamber of modified Shaw. Furthermore, "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Alternatively or additionally, it has been held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (See MPEP 2144.04 citing Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)).
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Shaw (US 20070093725 A1- previously cited) in view of in view of Candell (US 20180125391 A1 - previously cited) in view of Causevic (WO 2014127044 A1) as applied to claim 1, in view of Ahmad (US 9643186 B1 A1 - previously cited).
In regards to claim 18, modified Shaw teaches the portable breath gas analyzer according to claim 1. Modified Shaw fails to teach an acetone gas-specific metal oxide sensor. Ahmad teaches using an acetone gas-specific metal oxide sensor to measure the acetone content in breath to aid in the assessment and treatment of various health conditions (Ahmad Col.5, Line 30 - col. 6, line 34, and Col. 30, lines 32-63). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensor of modified Shaw to include the acetone gas-specific metal oxide sensor taught in Ahmad to allow for the device to measure acetone levels in the breath to aid in the assessment and treatment of various health conditions (Ahmad Col. 6, Lines 25-34).
In regards to claim 19, modified Shaw teaches the portable breath gas analyzer according to claim 1. Modified Shaw fails to teach a temperature sensor, moisture sensor or a combination thereof. Ahmad teaches a temperature sensor for detecting that a sample has been taken (Ahmad Col.6, Lines 56-60). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensor of modified Shaw to include the temperature sensor taught in Ahmad to allow for the device to detect that a sampling event has occurred.
Claims 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Shaw (US 20070093725 A1- previously cited) in view of in view of Candell (US 20180125391 A1 - previously cited) in view of Causevic (WO 2014127044 A1) in view of Atsalakis (US 20190120821 A1 - previously cited) as applied to claim 20, further in view of Ahmad (US 9643186 B1- previously cited) in view of Reddy (US 20200337594 A1-previously cited).
In regards to claim 21, modified Shaw teaches the device of claim 20. Modified Shaw fails to teach that the processor comprises a feature generating portion for generating features from the breath data signal detected by the sensor and a computing portion for processing the features to obtain the values indicating the illness identity. It is noted that while modified Shaw teaches that its processor is configured to obtain values indicating an illness identity (Shaw [0009]), it fails to provide details of how the processor obtains the values. Ahmad teaches a processor that comprises a feature generating portion for generating features from a breath data signal detected by a sensor and a computing portion for processing the features to obtain values indicating an illness identity (Col. 13, Line 44 – Col. 14, line 14). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the processor of Shaw in view of Atsalakis to comprise a feature generating portion for generating features from the breath data signal and a computing portion for processing the features to obtain the values indicating an illness identity, as Ahmad teaches that a processor comprising such a feature generating portion and computing portion can be used to obtain the values indicating an illness identity determined by Shaw. Doing so would merely combining prior art elements according to known methods to yield predictable result of generating features that can be used to identify an illness of a user. MPEP 2141.I
Modified Shaw in view of Ahmad fails to teach artificial intelligence method for generating features. Reddy teaches Reddy teaches using machine learning to generate features from breath data signal detected by a sensor ([0203]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the processor of Shaw in view of Ahmad to use machine learning to generate features like the method of Reddy. Doing so would further increase features sets ([0203]).
In regards to claim 22 modified Shaw teaches the device of claim further comprising generating features from the voltage data signal of the sensor (Ahmad Col. 14, Lines 2-14; FIG. 7 summarizes sample test results by showing the peak sensor output voltage as a function of analyte concentration).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable Shaw (US 20070093725 A1- previously cited) in view of in view of Candell (US 20180125391 A1 - previously cited) in view of Causevic (WO 2014127044 A1) as applied to claim 6, in view of Knestel (US 20190175065 A1)
In regards to claim 28, modified Shaw teaches a system where the main tube and the breath delivery tube are made of polyethylene and polypropylene. Modified Shaw fails to teach a system in which the main tube and the breath delivery tube are made of Teflon or polyethylene and polypropylene with a Teflon-coated inner surface. However, Knestel teaches a main tube and a breath delivery tube are coated with Teflon to repel dirt and water and improve hygiene (Knestel [0064]). It would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the main tube and the breath delivery tube of modified Shaw to be Teflon coated like the pieces of Knestel. Doing so would keep the tubes of Shaw clean by repelling dirt and water.
Response to Arguments
Applicant's arguments filed 08/08/2025 regarding the 112(a) objections of claims 21-23 have been fully considered but they are not persuasive. The specification does not provide evidence for the generating features using an artificial intelligence method. As such, there is no support for the claimed subject matter that would allow one of ordinary skill in the art to conclude that the invention had possession of the claimed invention at the time of filing.
Applicant’s arguments, filed 05/13/2022, with respect to the rejections of claims 1 under U.S.C 112(b) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.
Applicant’s arguments, filed 05/13/2022, with respect to the rejections of claims 25 under U.S.C 112(b) have been fully considered and are not persuasive. However, the claim has been amended to omit the indefinite claim language, and for this reason the rejection has been withdrawn.
Applicant’s arguments, see page 12, filed 08/08/2025, with respect to the rejection of claim 1 under U.S.C 103 Shaw have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Shaw (US 20070093725 A1- previously cited) in view of in view of Candell (US 20180125391 A1 - previously cited) in view of Causevic (WO 2014127044 A1).
Applicant’s arguments, see pages 13-14, filed 08/08/2025, with respect to the rejection of claim 1 under U.S.C 103 Shaw have been fully considered but are not persuasive. Examiner contends that the specification does not teach that the “the breath delivery tube being installed at a position 0.5 to 75 mm far from the mouthpiece in a horizontal direction” facilitates the precise control of breath pattern, and therefore the argument of routine optimization is sustained. In regards to the rest of the applicant’s arguments with regards to the routine optimization arguments of the examiner’s office action, the only measurement that the specification discloses an advantage or unexpected result for is the breath flow rate of 0 to 3L/min. Any other measurement within the claims do not an advantage or unexpected result according to the provided spec, and therefore can be rejected on the basis of routine optimization. Alternatively or additionally, it has been held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (See MPEP 2144.04 citing Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/LUCY EPPERT/ Examiner, Art Unit 3791
/MATTHEW KREMER/ Primary Examiner, Art Unit 3791